A Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT03403790|
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment|
|Depression Bipolar Disorder||Drug: Quetiapine|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Patients with depression in bipolar disorder
Patients with depression in bipolar disorder who are treated with quetiapine extended-release tablets for the first time
Oral (extended-release tablet)
Other Name: Bipresso
- Safety assessed by incidence of serious adverse events [ Time Frame: Up to Week 12 ]To assess incidence of serious adverse events as a criteria of safety variables.
- Safety assessed by incidence of adverse drug reactions [ Time Frame: Up to Week 12 ]To assess incidence of adverse drug reactions as a criteria of safety variables.
- Safety assessed by laboratory values and changes from baseline over time [ Time Frame: Up to Week 12 ]To assess profile of laboratory value transition and potential clinical significance as a criteria of safety variables. The investigators will assess the severity and clinical relevance, and will report as an adverse event as necessary.
- Safety assessed by vital signs: Blood pressure (sitting) [ Time Frame: Up to Week 12 ]To assess blood pressure as a criteria of safety variables
- Safety assessed by vital signs: Pulse rate (sitting) [ Time Frame: Up to Week 12 ]To assess pulse rate as a criteria of safety variables
- Safety assessed by 12-lead electrocardiogram [ Time Frame: Up to Week 12 ]To assess 12-lead electrocardiogram as a criteria of safety variables
- Safety assessed by body weight [ Time Frame: Up to Week 12 ]To assess body weight as a criteria of safety variables
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and up to Week 12 ]To assess MADRS as a criteria of efficacy variables
- Change from baseline in Clinical Global Impression-Bipolar-Severity of illness (CGI-BP-S) [ Time Frame: Baseline and up to Week 12 ]To assess CGI-BP-S as a criteria of efficacy variables
- Efficacy assessed by Clinical Global Impression-Bipolar-Change (CGI-BP-C) [ Time Frame: Up to Week 12 ]To assess CGI-BP-C as a criteria of efficacy variables
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403790
|Contact: Astellas Pharma Inc.||+firstname.lastname@example.org|
|Study Director:||Central Contact||Astellas Pharma Inc|